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Dermal Filler
Revanesse Shape + and Juvederm Voluma for Mid-face Volume Deficit
N/A
Waitlist Available
Research Sponsored by Prollenium Medical Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two facial fillers, Revanesse Shape + and Juvederm Voluma, in adults aged 22-65 who have lost facial fat. The fillers are injected to restore volume and improve facial appearance, with lidocaine reducing injection pain. Juvederm Voluma is known for its long-lasting and natural results.
Eligible Conditions
- Mid-face Volume Deficit
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2/week 2, visit 3/month 1, visit 4/month 2, visit 5/month 3, visit 6/month 6, visit 7/month 12 and visit 8/month 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to Visit 6/Month 6 in the Medicis Mid-face Volume Scale (MMVS) score
Secondary study objectives
Change from baseline to Visit 7/Month 12 in the Medicis Mid-face Volume Scale (MMVS) score
Change in the Nasolabial Folds Wrinkle Severity Rating Scale score at Visit 2/Week 2, Visit 3/Month 1, Visit 4/Month 2, Visit 5/Month 3, Visit 6/Month 6, Visit 7/Month 12 and Visit 8/Month 15
Percent of subjects with clinical success at Visit 6/Month 6 where success is defined as a subject with at least a 1-grade improvement from baseline on the Investigator Global Aesthetic Improvement Score (iGAIS).
+2 moreOther study objectives
Self-perception of age for each side of the face
Subject feel of mid-face for each side of the face
Face
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Revanesse Shape + with LidocaineActive Control2 Interventions
Revanesse Shape + with Lidocaine is a clear, colorless gel in 1.2 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine
Group II: Juvederm Voluma with LidocaineActive Control2 Interventions
Juvederm Voluma with Lidocaine is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine.
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Who is running the clinical trial?
Prollenium Medical Technologies Inc.Lead Sponsor
6 Previous Clinical Trials
581 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild to moderate muscle weakness on one side of your face.You have had certain facial treatments or have specific facial conditions like scars, skin disease, keloid formation, or inflammatory processes.You had cancer within the last 5 years, with some special cases allowed.You plan to lose a lot of weight during the study.You have certain abnormal test results or conditions before starting the study.Men and women who are not pregnant, not breastfeeding, and are between 22 and 65 years old.People who want to improve the appearance of their mid-face and have a certain score for the severity of their mid-face wrinkles.
Research Study Groups:
This trial has the following groups:- Group 1: Revanesse Shape + with Lidocaine
- Group 2: Juvederm Voluma with Lidocaine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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